Adverse Event Reporting
| VAERS ID | 1432734 |
|---|---|
| Gender | Female |
| Age | 71 |
| StateCode | |
| Pharmaceutical Company | MODERNA |
| Lot Number | 044B21A |
| Number of vaccinations | 1 |
| Vaccinated | 2021-05-03 |
| Onset | 2021-05-05 |
| Condition | Hospitalized Permanent Disability |
Symptoms
- Confusional state
- Hypertension
- Facial paralysis
- Diabetes mellitus
- Ischaemic stroke
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Confusional state; Diabetes mellitus; Facial paralysis; Hypertension; Ischaemic stroke; This case was received via VAERS (Reference number: 1358541) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.
This regulatory authority case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
044B21A) for COVID-19 vaccination.
No Medical History information was reported.
On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
On 05-May-2021, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criteria hospitalization and disability), DIABETES MELLITUS (Diabetes mellitus) (seriousness criteria hospitalization, disability and medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization, disability and medically significant), HYPERTENSION (Hypertension) (seriousness criteria hospitalization and disability) and ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criteria hospitalization, disability and medically significant).
The patient was hospitalized on 05-May-2021 due to CONFUSIONAL STATE, DIABETES MELLITUS, FACIAL PARALYSIS, HYPERTENSION and ISCHAEMIC STROKE.
At the time of the report, CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) had not resolved.
The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medications were given by the reporter.
No Treatment information were provided by the reporter.
Patient received first dose of vaccine on 5/3/21.
On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and facial droop.
Patient was Diagnosed with acute ischemic stroke, new diagnosis hypertension and diabetes mellitus.
Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.